Subjects randomized to the placebo arm will receive Placebo subcutaneously every 4 weeks

Study Arm (s)

Experimental: Evolocumab (AMG 145)

Evolocumab (AMG 145)

Intervention: Biological: Evolocumab (AMG 145)

Placebo Comparator: Placebo

Placebo

Intervention: Other: Placebo

Publications *

Not Provided

* Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ICMJE

Active, not recruiting

Enrollment ICMJE

970

Estimated Completion Date

November 2016

Estimated Primary Completion Date

April 2016 (final data collection date for primary outcome measure)

Eligibility Criteria ICMJE

Inclusion Criteria:

Clinical indication for coronary angiography

Subjects already taking statin therapy, niacin or ezetimibe at screening must have been on a stable dose for at least 4 weeks prior to screening LDL-C. Subjects not taking lipid-regulating therapy must enter the study via a lipid stabilization period. Subjects who are intolerant to statins must meet statin intolerance entry criteria

Fasting LDL-C ≥ 80 mg/dL (2.07 mmol/L) with or without additional risk factors, or, LDL-C ≥ 60 -<80 mg/dL (1.55-2.07 mmol/L) in the presence of one major or three minor risk factors

Subjects must meet the following criteria at the qualifying coronary catheterization procedure:

Evidence of coronary heart disease (at least one lesion in a native coronary artery that has >20% reduction in lumen diameter) or prior PCI

Left main coronary artery <50% reduction in lumen diameter by visual estimation

Target Coronary Artery for IVUS must be accessible to the IVUS catheter, must not have a >50% reduction in lumen diameter within the target segment (and at least 40mm in length); cannot have undergone prior PCI or CABG and is not a candidate for intervention over the next 18 months. It may not be a bypass graft, bypassed vessel or culprit vessel for previous MI.